SaMD

Intermediate

Software regulated as a medical device.

Full Definition

Software regulated as a medical device.

Keywords

software as medical device

Domains

AI in Healthcare

Related Terms

Dataset Shift related to

Differences between training and deployed patient populations.

 Algorithmic Bias related to

Unequal performance across demographic groups.

 Informed Consent related to

Patient agreement to AI-assisted care.

 Risk Stratification related to

Grouping patients by predicted outcomes.

 Prognostic Model related to

Predicting disease progression or survival.

 Clinical Validation related to

Testing AI under actual clinical conditions.

 FDA Clearance related to

US approval process for medical AI devices.

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